Phase I and Bioequivalence Studies

AmeRuss offers services in phase I and bioequivalence studies in cooperation with specialized phase I providers in Russia and the US that include:

  • Phase I study protocol and CRF development
  • Study conduct in healthy subjects and special populations
  • Regulatory submissions and approvals
  • Importation and handling of study products and clinical study supply including:
    1. Customs clearance
    2. Study product and clinical supply depot in Moscow
    3. Shipment of study products to study sites
    4. Tracking study product distribution
    5. Retention and destruction of study products as required
  • Interim Monitoring Visits
  • Data Management
  • Statistical analysis plans
  • Statistical analysis of pharmacokinetic and pharmacodynamic data
  • Statistical analysis of safety data
  • Reporting